Evaluation of Angioplasty in the Treatment of Chronic Cerebrospinal Venous Insufficiency (CCSVI) in Multiple Sclerosis

Community Care Physicians, P.C.

Status: Terminated

Conditions: Multiple Sclerosis

Treatments: Other: Observation; Procedure: Angioplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT01201707

2794

Details and patient eligibility

About

The study is being done to determine if venous angioplasty is an effective treatment for chronic cerebrospinal venous insufficiency (CCSVI). In this condition, areas of narrowing or blockages are present in the internal jugular or azygos veins (veins which drain blood from the central nervous system) and these blockages may be associated with symptoms classically attributed to MS. Therefore, angioplasty may help to improve the symptoms associated with CCSVI and multiple sclerosis (MS). In this study, the investigators will evaluate the effectiveness of angioplasty in the treatment of CCSVI by comparing two the outcomes of two groups of patients: one group with CCSVI diagnosed on a venogram and treated with angioplasty and one group with CCSVI diagnosed on a venogram but not treated. The patients enrolled in this study, and the neurologist evaluating patients after the procedure, will not know whether or not they were treated with angioplasty.

Enrollment: 18 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who are willing to comply with the protocol requirements and can be contacted by telephone
• Patients 18-60 years of age
• Patients with clinically definite multiple sclerosis by Polman criteria
• Patients with a history of MS as defined above with an EDSS between 3-6.
• Patients with a significant stenosis of the internal jugular or azygos vein on the basis of magnetic resonance venography or Doppler ultrasound.

Exclusion criteria

• Patients with renal insufficiency based on an estimated GFR <45
• Patients with a known severe allergy to iodine or gadolinium-based contrast agents which cannot be adequately pre-medicated
• Patients with a known allergy to nickel
• Patients who pregnant
• Patients with a contraindication to anticoagulation or anti-platelet medication
• Patients with a contraindication to drugs used for conscious sedation during interventional procedures, including Versed and Fentanyl
• Patients with a history of deep venous thrombosis of the lower extremities
• Patients with occlusion of the right and left common femoral veins
• Patients who have had any changes in their disease modifying drug regimen for MS during the 6 months prior to enrollment in this trial. This would include the addition of any new medications, a change in the dosage of any medications, or the removal of any medications from a patient's drug regimen
• Patients with a life expectancy <18 months
• Patients who are currently enrolled or who plan to enroll in other investigations that conflict with follow-up testing or confounds data in this trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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18 participants in 2 patient groups

Treatment of CCSVI with Angioplasty

Experimental group

Description:

At the time of venography, these patients will have had a significant lesion (blockage) in the internal jugular and/or the azygos vein that will be treated with angioplasty.

Treatment:

Procedure: Angioplasty

Observation of CCSVI

Sham Comparator group

Description:

At the time of venography, these patients will have had a significant lesion (blockage) in the internal jugular and/or the azygos vein that will not be treated with angioplasty. These patients will be observed after treatment and compared to those patients who received treatment.

Treatment:

Other: Observation